Downstream Manufacturing Associate III
Confirmed on the employer's own hiring board on Nov 8, 2026. First seen by Alion on Nov 5, 2026. Planet Pharma scores B on the Alion truth index.
Pay range: 30-40/hr
*depending on experience
Position Overview:
The Downstream Manufacturing Associate III (Lead) provides technical leadership and operational coordination for downstream manufacturing activities within a cGMP environment. This role is responsible for leading purification operations, supporting manufacturing readiness, troubleshooting complex process issues, coordinating cross-functional activities, and driving operational excellence initiatives while ensuring successful batch execution.
Key Responsibilities:
Manufacturing Leadership
* Lead daily downstream manufacturing operations and provide shop-floor technical support.
* Coordinate execution of manufacturing campaigns and purification schedules.
* Ensure manufacturing readiness, equipment availability, and material preparedness for batch execution.
* Serve as the primary technical resource during downstream manufacturing operations.
* Provide real-time decision support during process execution and batch recovery activities.
Downstream Processing
* Lead all purification operations including Protein A capture, viral inactivation, ion exchange chromatography, UF/DF, viral filtration, and final bulk drug substance processing.
* Oversee operation and performance of chromatography skids, AKTA systems, BioSC, TFF systems, and filtration equipment.
* Monitor critical process parameters and ensure adherence to process specifications.
* Troubleshoot process and equipment issues to maintain operational continuity.
* Support implementation of process improvements and manufacturing optimization efforts.
Documentation & Compliance
* Lead preparation and revision of:
o Standard Operating Procedures (SOPs)
o Master Batch Records (MBRs)
o Manufacturing Forms and Logbooks
o Equipment and Process Documentation
* Support deviation investigations, CAPAs, change controls, and risk assessments.
* Ensure continuous inspection readiness and GMP compliance.
* Participate directly in regulatory inspections and client audits.
* Support review and approval of manufacturing documentation for batch release readiness.
Cross-Functional Coordination
* Coordinate activities between Manufacturing, QA, QC, MSAT, Validation, Engineering, Facilities, Warehouse, and Supply Chain teams.
* Support technology transfer projects from process development through GMP manufacturing.
* Participate in process validation, PPQ campaigns, and commercial manufacturing programs.
* Lead manufacturing readiness reviews and campaign planning meetings.
* Drive continuous improvement and operational excellence initiatives.
Coaching & Development
* Train, mentor, and develop Associate I and Associate II personnel.
* Provide technical coaching and floor-based leadership.
* Support qualification programs and onboarding activities.
* Assist supervisors with scheduling, work assignments, and personnel development plans.
Qualifications:
Education & Experience
* Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience.
* Previous lead operator, project coordination, or team leadership experience preferred.
* Experience supporting late-stage clinical or commercial biologics manufacturing preferred.
Required Skills
* Advanced expertise in downstream purification operations and biologics manufacturing.
* Extensive experience with Protein A and polishing chromatography processes.
* Strong hands-on experience operating AKTA chromatography systems and TFF platforms.
* Advanced knowledge of viral filtration, UF/DF, and sterile filtration processes.
* Strong understanding of GMP regulations, manufacturing systems, and documentation requirements.
* Proven leadership, decision-making, and organizational skills.
* Excellent troubleshooting and problem-solving capabilities.
* Ability to effectively coordinate cross-functional manufacturing activities.
Preferred Skills
Experience supporting:
* Technology Transfers
* Process Validation and PPQ Campaigns
* Commercial Manufacturing Operations
* Regulatory Inspections and Client Audits
* CAPA and Deviation Management
* Continuous Improvement and Lean Manufacturing Initiatives
Physical Requirements
* Ability to stand for extended periods.
* Ability to bend, reach, and lift up to 50 pounds.
* Ability to work in cleanroom environments while wearing required PPE.